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Completed

NCT Number: NCT02389829

Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center--Einstein

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Migraine headache (International Classification of Headache Disorders 3B criteria)

Exclusion criteria

  • Brain imaging ordered
  • Fever
  • Objective neurological findings
  • Pregnancy/ breast feeding
  • Allergy/ contraindication to investigational medication
  • History of addiction to opioids, use of methadone, any use of opioids previous 30 days

Treatment and study plan

Hydromorphone

Drug

Other names: Dilaudid

prochlorperazine

Drug

Other names: Compazine

diphenhydramine

Drug

Other names: Benadryl

Primary outcomes

  1. Number of Participants With Sustained Headache Relief Assessed by Self-evaluation

    Time frame: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department

    Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours, without use of addition medication. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.

Secondary outcomes

  1. Number of Participants Needing Rescue Medication as Assessed by Questionnaire

    Time frame: 48 hours after discharge from Emergency Department

    Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication.

  2. Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire

    Time frame: 48 hours after discharge from Emergency Department

    Participants were asked to make evaluation of pain status since discharge. Those achieving headache level "mild" or "none" for 1 hour are considered to achieve short term headache relief.

  3. Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire

    Time frame: 48 hours after discharge from Emergency Department

    Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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